Kornimate/medical-research-clean huggingface dataset:
prospective study looking at quality of life measures in non-ischaemic cardiomyopathy after mitral valve repair

Conditions: Mitral Valve Insufficiency; Dilated Cardiomyopathy; Congestive Heart Failure

Summary: * chronic severe mitral regurgitation can lead to symptoms and left ventricular dysfunction. * the purpose of this study is to prospectively follow patients with non-ischaemic cardiomyopathy who are eligible for mitral valve repair surgery and primarily measure the quality of life through the minnesota living with heart failure questionnaire \& the kansas city cardiomyopathy questionnaire.

* chronic mitral regurgitation (mr) usually spirals into a vicious cycle of left ventricular (lv) volume overload, lv dilatation, mitral annular dilatation and more mr. "mr begets mr". eventually symptoms and lv dysfunction ensue. however, it can often be treated medically or surgically. medical therapy is primarily afterload reduction and diuretics. surgically, there are two options, either mitral valve repair or replacement. * a number of retrospective studies have demonstrated improved lv function and survival in patients undergoing valve repair compared to valve replacement with or without subvalvular preservation. in one report, for example, patients who underwent valve repair were compared to patients who underwent valve replacement. the report found that the former group had lower operative mortality, a greater increase in lv ejection fraction and higher overall ten year survival. * the bulk of the literature at present addresses left ventricular dimensions, ejection fraction, geometry and new york heart association functional class, but few have addressed quality of life measures. in addition, most of these studies were retrospective and the majority of patients had concomitant ischaemic heart disease. * even though the studies concerning quality of life after mitral valve surgery have been few, nevertheless, some have addressed isolated valve surgery without concomitant bypass surgery and have shown improved quality of life, though follow up in some was limited to 3 months. we will follow our population for 12 months after surgical repair. * we will primarily look at subjective measures for quality of life such as the minnesota living with heart failure questionnaire \& the kansas city cardiomyopathy questionnaire, as subjective measures are becoming more and more important following cardiac surgery. patients will serve as their own controls and all study parameters will be compared pre- and post surgery.

Eligibility criteria:
inclusion criteria: * patients that fulfill surgical criteria set by the 2006 acc/aha guidelines for the management of patients with valvular heart disease. * symptomatic mitral regurgitation with left ventricular dysfunction (lvef \< or = 40%) on maximal medical therapy exclusion criteria: * mitral valve replacement * concomitant coronary artery bypass surgery * patient unable to give informed consent

Keywords: non-ischaemic cardiomyopathy
traditional chinese medicine xiang-sha-liu-jun granules in patients with postprandial distress syndrome(pds)

Conditions: Postprandial Distress Syndrome

Summary: functional dyspepsia (fd), which is one of the most common gastrointestinal disorders with high disease burden. postprandial distress syndrome (pds) is a common subtype of fd. although the effectiveness of chinese herbal formula of xiang-sha-liu-jun granule (xsljg) for alleviating pds symptoms has been assessed in previous studies, more convinced evidence of randomized placebo-controlled study is needed.


Eligibility criteria:
inclusion criteria: * i)aging between 18 and 75 years, able to read and write chinese; * ii)have a tcm diagnosis of spleen deficiency and qi stagnation pattern; * iii) having normal esophagogastroduodenoscopy results within 6 months; * iv) having normal liver and renal function confirmed by blood tests within 3 months; * v) being diagnosed as pds of fd by a specialist consultation; * vi）receiving no other treatments during the study; * vii）voluntarily agreeing with the study protocol and signing a written informed consent. exclusion criteria: * i)having peptic ulcer or gastroesophageal reflux disease confirmed by esophagogastroduodenoscopy; * ii) having obvious signs of irritable bowel syndrome; * iii) having alarm symptoms (weight loss, black or tar stool, or dysphagia); * iv) having serious structural disease (disease of heart, lung, liver or kidney) or mental illness; * v) having had surgery related with the gastrointestinal tract, except for appendectomy more than six months ago; * vi) pregnant or breastfeeding; * vii) being taking drugs which may affect the gastrointestinal tract; a minimum wash-out period of two weeks is required before participating in the trial; * viii) having a problem of malabsorption or maldigestion; * ix) having a history of allergies to the studied drugs and food; * x) having difficulties in attending the trial (such as paralysis, serious mental illness, dementia, renal diseases, stroke, coronary atherosclerotic heart diseases, diabetes or mental diseases, illiteracy); * xi) unwilling to sign the informed consent.
analyzing the factors in ulcerative colitis patients' clinical trial experiences

Conditions: Ulcerative Colitis

Summary: taking part in clinical trials usually favors a particular demographic group. but there is limited research available to explain what trial attributes affect the completion of these specific demographic groups. this study will admit a wide range of data on the clinical trial experience of ulcerative colitis patients to determine which factors prevail in limiting a patient's ability to join or finish a trial. it will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future ulcerative colitis patients.


Eligibility criteria:
inclusion criteria: * patient is at least 18 years of age * diagnosis of ulcerative colitis * ability to understand the study procedures, benefits and risks, and sign a written informed consent document. exclusion criteria: * inability to perform regular electronic reporting * women who are pregnant, intend to become pregnant, or are lactating * inability to perform regular electronic reporting

Keywords: ulcerative colitis
taperloc complete microplasty vs taperloc complete standard: randomized controlled study on bone mineral density

Conditions: Osteoarthritis; Avascular Necrosis; Traumatic Arthritis; Rheumatoid Arthritis; Legg-Perthes Disease

Summary: the primary purpose of this study is to measure the postoperative changes in bone mineral density, comparing the taperloc complete reduced distal microplasty stem and the standard length taperloc complete reduced distal stem.

the taperloc microplasty cementless stem is designed to transmit load to the proximal femur, thereby preserving bone density, and preventing long term instability and loosening secondary to proximal bone resorption. the primary aim of this study is therefore to compare the postoperative changes in bone density with the taperloc microplasty stem, using the standard length taperloc stem as a control. in addition, the taperloc stem has historically had a neck angle of 138°. there have been criticisms that this neck angle is too high for the typical korean population. the newer taperloc complete system (both microplasty and standard length) has a neck angle of 133°. a secondary aim is occurrence ratio of thigh pain difference between microplasty and standard stem in korean population

Eligibility criteria:
inclusion criteria: * patients suitable for primary total hip replacement patients with degenerative joint disease (inflammatory or non-inflammatory) or any of the composite diagnoses of: 1. osteoarthritis 2. avascular necrosis 3. legg perthes 4. rheumatoid arthritis 5. diastrophic variant 6. fused hip 7. sequelae of slipped capital epiphysis 8. traumatic arthritis 9. patients aged over 20 10. patients must be able to understand instructions and be willing to return for follow-up exclusion criteria: * absolute contraindications include: infection, sepsis, and osteomyelitis. relative contraindications include: 1. uncooperative patient or patient with neurologic disorders who are incapable of following directions, 2. small femoral canal 2) severe osteoporosis (patients over 65 years old) 3) metabolic disorders which may impair bone formation, 4) osteomalacia, 5) distant foci of infections which may spread to the implant site, 6) rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram, and 7) vascular insufficiency, muscular atrophy, or neuromuscular disease. 8) pregnancy 9) fracture of the pelvis 10) subcapital fractures
comparing the performance of automated breast ultrasonography to hand-held whole breast ultrasonography in breast cancer treatment response assessment

Conditions: Breast Carcinoma

Summary: this study compares the performance of automated breast ultrasonography and conventional hand-held whole breast ultrasonography when checking for response to breast cancer treatment. breast ultrasonography is operator dependent and time-intensive. automated breast ultrasonography scanners were developed to allow standardization of ultrasound scanning and scanning to be performed by any technologist, with or without previous ultrasound experience, without physician involvement. this study may validate the use of the automated breast ultrasonography.

primary objective: i. to estimate and compare the accuracy of automated breast ultrasonography (abus) and hand-held whole breast ultrasonography (wbus) in predicting pathology complete response (pcr) with relative tumor volume change, using the receiver operating characteristic (roc) curve analysis. secondary objectives: i. to evaluate the reproducibility of tumor volume measurements obtained by abus and handheld wbus, respectively, using data collected at baseline for initial staging. ii. to assess the agreement in relative tumor volume change (rc) (end-of-treatment versus \[vs.\] pre-treatment) between abus and wbus. iii. to estimate and compare the following diagnostic measures for abus and wbus: sensitivity, specificity, positive predictive value (ppv) and negative predictive value (npv). outline: patients undergo abus over 15 minutes followed by wbus over 30 minutes at baseline, mid-treatment and pre-surgery (end of treatment).

Eligibility criteria:
inclusion criteria: * the subjects to be studied will include patients seen in md anderson breast imaging clinic at the texas medical center (tmc) * with breast cancer or suspicion of breast cancer * male or female who is older than 18 years of age * of any race * who consent to obtain technologist performed breast ultrasound and automated breast ultrasound * english and non-english speakers (with language interpreter to assist in translation for non-english speakers) exclusion criteria: * patient who is less than 18 years of age * imaging obtained outside of md anderson tmc * surgery pathology from outside of md anderson will be excluded from this study
opt-302 with aflibercept in neovascular age-related macular degeneration (namd)

Conditions: Neovascular Age-related Macular Degeneration

Summary: a 2-year phase 3, multicentre, randomised, parallel-group, sham-controlled, double-masked study. primary efficacy will be determined at week 52.


Eligibility criteria:
inclusion criteria: * active subfoveal cnv lesion or juxtafoveal cnv lesion with foveal involvement that is secondary to amd in the study eye. * an etdrs bcva score between 60 and 25 (inclusive) letters in the study eye. main exclusion criteria: * any previous treatment for neovascular amd. * clinically significant ocular disorders (other than neovascular amd), which may interfere with assessment of bcva, assessment of safety, or fundus imaging. * any current (or history of a) social, psychological, or medical condition that precludes enrolment into the study. * additional inclusion/exclusion criteria apply.

Keywords: namd wet amd wet macular degeneration macular degeneration eye diseases retinal diseases retinal degeneration
allogeneic mesenchymal stromal cells in elderly patients with hip fracture

Conditions: Femoral Neck Fracture

Summary: prospective, unicenter, randomized, open-label, single-dose, two-arms blinded assessor pilot study. thirty-two (32) elderly patients with hip fracture will be randomized to one of the two treatment-arms (xcel-mt-osteo-beta or standard treatment) and be followed for 12 month with the primary objective of safety. secondary objectives are efficacy through axial tomography and xray, clinical efficacy and quality of life questionnaire.

prospective, unicenter, randomized, open-label, single-dose, two-arms blinded assessor phase i-ii pilot study. thirty-two (32) elderly patients (70-85 years of age) with type 31a2 y 31a3 fracture of the femur (ao/asif (association for the study of internal fixation) classification) admitted at the emergency room of the hospital clinic of barcelona will be randomized 1:1 to one of the two treatment-arms (endomedullary nailing + xcel-mt-osteo-beta or isolated endomedullary nailing as the standard treatment). once surgically treated, patients will be followed for 12 month with the primary objective of safety. secondary objectives are efficacy through axial tomography and xray, clinical efficacy and quality of life questionnaire (euroqol-5d).

Eligibility criteria:
inclusion criteria: 1. patient between70 and 85 years old 2. proximal femur fracture type 31a3 31a2 classification ao/asif. 3. deambulation prior to fracture. 4. written informed consent of the patient or family members. exclusion criteria: 1. presence of implants at proximal femur level. 2. presence of local or systemic septic process. 3. septic arthritis. 4. dementia of any type. 5. hematological and biochemical analysis with significant alterations that contraindicate surgery. 6. patients with positive serology for hiv 1 and 2, hepatitis b, hepatitis c and syphilis. 7. neoplastic disease detected in the last five years or without complete remission. 8. immunosuppressive status. 9. patients who received corticosteroids in the 3 months prior to study initiation. 10. simultaneous participation in another clinical trial or treatment with another investigational product within 3 months prior to inclusion in the study. 11. other conditions or circumstances that may compromise the patient's participation in the study according to medical criteria. 12. patient refusal to be followed by a period that may exceed the clinical trial itself.

Keywords: mesenchymal stromal cells stem cells elderly allogeneic bone marrow bone regeneration fracture
neuro-ocular baselines in a sports setting

Conditions: Wave Form Signals Coming From the Eye in a Healthy Cohort

Summary: rebion (rebiscan, inc) has developed a noninvasive, handheld device that uses retinal birefringence scanning (rbs) to rapidly assess eye fixation and retinal integrity in adults and children. the proprietary technology uses a scanned annulus of polarized laser light to create a signature that confirms central fixation within seconds. the project described herein aims to provide accurate assessment of brain dysfunction in tbi (traumatic brain injury) patients through the use of the developed device, which is called the head and intraocular trauma test (hitt) device.


Eligibility criteria:
inclusion criteria: * student-athletes who present to schools affiliated with the bluegrass sports clinica * engaged in sports * older or equal to 11 years of age, and less than 21 years of age. * provide informed consent; youths must have their parents sign the informed consent document. children will be presented with a written assent statement and that they will be asked to sign the assent document. exclusion criteria: * catastrophic polytrauma that would interfere with follow-up and outcome assessment * amblyopia/strabismus * pregnancy in female subjects * any injury to eye including, puncture, scratch, occlusion, fracture to orbital socket (or any fracture to face that would negatively impact eye movement/vision) that would interfere with ability to complete study-device assessment. * history of poor vision prior to injury (visual acuity worse than 20/40 in either eye) * intoxication or chemical impairment at time of examination (upon initial presentation)
fragmin in the treatment of acute deep-vein thrombosis with or without pulmonary embolism in cancer patients

Conditions: Acute Deep Vein Thrombosis

Summary: to collect postmarketing data about fragmin safety and efficacy in the treatment of deep vein thrombosis with or without pulmonary embolism in cancer patients.

method: consecutive patient sampling. patients were (are) included in the study in consecutive manner if they fulfilled the inclusion criteria and any of the exclusion criteria were not present.

Eligibility criteria:
inclusion criteria: * male or female patient of 18 - 70 years of age. * cancer patient with proven deep-vein thrombosis with or without pulmonary embolism confirmed by combination of clinical signs and symptoms, pulmonary hypertension on echocardiogram, x-ray examination of the lung and eventually perfusion/ventilation scan of the lung. exclusion criteria: * bleeding * hypersensitivity to fragmin® or other low-molecular weight heparins. * serum creatinine level \> 150 umol/l. * platelet count of less than 100 000 per cubic millimeter at the beginning of the therapy. * patient on oral anticoagulation therapy in the last 7 days.
left atrial appendage (laa) clot with severe mitral stenosis

Conditions: Left Atrial Appendage Aneurysm; Mitral Stenosis

Summary: consecutive patients with severe mitral stenosis and clot in left atrial appendage (laa) on transesophageal echocardiography fulfilling the inclusion criteria will be recruited for this study. an acuson 128-xp echocardiographic system equipped with omniplane and biplane transesophageal probes will be used for this study. tee followed by ct angiography will be performed according to the standard procedure after obtaining informed consent.

consecutive patients with severe mitral stenosis and clot in left atrial appendage (laa) on transesophageal echocardiography fulfilling the inclusion criteria will be recruited for this study. an acuson 128-xp echocardiographic system equipped with omniplane and biplane transesophageal probes will be used for this study. tee followed by ct angiography will be performed according to the standard procedure after obtaining informed consent. demographic profile of the patients will be recorded like gender and age. and baseline tee will be interpreted and parameters such as mean mvo (cm2), mean mpg (mmhg), and mean la size (ap diameter, cm) will be recorded. laa morphologies will be classified as per the operational definition. all the patients will be put on oral anticoagulation with warfarin. the international normalized ratio (inr) will be maintained between 2.5 and 3.5. patients will be prescribed with warfarin initial with 5 mg of daily dosage. weekly inr monitoring will be performed via weekly calls to each and every patients and their inr level will be obtained. warfarin daily dosage will be adjusted after every month based on target inr range. repeat tee will be performed after three (3) months in all the patients. and presence and absence of clot in different types of laa will be recorded.

Eligibility criteria:
inclusion criteria: * age between 18 to 65 years. * both male and female. * patients with server mitral stenosis. * patients with laa clot on tee. * patients prescribed with anticoagulation (warfarin therapy). exclusion criteria: * patients with severe mr * patients with severe as * patients with nyha class iv * patients whose valve morphology precluded ptmc

Keywords: mitral stenosis left atrial appendage anticoagulation echocardiography
multisite tissue oxygenation guided perioperative care in cardiac surgery

Conditions: Brain Ischemia Hypoxia; Muscle; Ischemic; Muscle Hypoxia

Summary: the bottomline-cs trial is an international, open, single-center, pragmatic, randomised controlled trial to investigate whether multisite tissue oxygen saturation monitoring-guided perioperative care reduces composite complications within 30 days of randomization in off-pump coronary artery bypass grafting.

short title: bottomline-cs trial methodology: international, open, single-center, pragmatic, randomised controlled trial research sites: tianjin chest hospital objectives: to investigate whether multisite tissue oxygen saturation monitoring-guided perioperative care reduces composite complications within 30 days of randomization in off-pump coronary artery bypass grafting number of patients: 1960 patients (980 per arm, two arms) inclusion criteria: patients aged ≥ 60 years undergoing elective off-pump coronary artery bypass grafting exclusion criteria: patient refusal, clinician refusal, preoperative requirement of respiratory support (intubation, cpap or bipap, or high-flow oxygen (\>10 l/min)), preoperative requirement of external cardiac assist devices, emergent or urgent surgery, patients expected to die within 30 days, current participation in another clinical trial statistical analysis: analyses will be performed on a modified intention-to-treat basis including all randomized patients who had undergone the scheduled surgery and had the record of the primary outcome. summary statistics for each group, treatment effects, 95% confidence intervals, and p values will be presented for primary and secondary outcomes, and process measures. the primary outcome is a composite of complications arising within 30 days from randomization and will be analyzed using a logistic regression model. proposed start date: may 1, 2021 (first patient to be recruited) proposed end date: april 30, 2023 (last patient to be recruited) study duration: 48 months (starting from the first patient recruitment, spanning patient recruitment, data analysis, and manuscript writing and submission)

Eligibility criteria:
inclusion criteria: * patients aged ≥ 60 years scheduled for elective off-pump cabg. exclusion criteria: * inability or refusal to provide consent of participation * preoperative requirement of respiratory support (intubation, cpap or bipap, or high-flow oxygen (\>10 l/min)) * preoperative requirement of external cardiac assist device * urgent or emergent surgery * patients expected to die within 30 days of randomization

Keywords: cerebral tissue oxygen saturation muscular tissue oxygen saturation cardiac surgery complications multisite tissue oxygenation monitoring
characterization of human autoantibody titers after central nervous system insult

Conditions: Brain Injuries, Traumatic; Spinal Cord Trauma; Intracranial Neoplasm

Summary: the aim of the study is to quantitate central nervous system (cns) autoantibody development in human blood using elisa after human brain injury, spinal cord injury, and intra-axial brain surgeries.

study objectives: we aim to: 1. quantitate cns autoantibody development in human blood using elisa after human brain injury, spinal cord injury, and intra-axial brain surgeries. we also aim to characterize the temporal course of this response. 2. characterize how cns autoantibody levels correlate with specific injury patterns as well as radiographic and clinical measures of injury severity. 3. determine how intercurrent infection and a history of prior cns insult affects the temporal course and magnitude of autoantibody production.

Eligibility criteria:
inclusion criteria: * have a severe traumatic brain injury * have spinal cord injury asia grade a, b or c * undergoing resection of intra-axial brain tumors exclusion criteria: * participant who is pregnant